Documentation of published clinical trials and ... - Institut Hiscia
Documentation of published clinical trials and ... - Institut Hiscia
Documentation of published clinical trials and ... - Institut Hiscia
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Tumour remissions 4.1<br />
The regression <strong>of</strong> tumours or metastases can be classified into 4 categories, based on<br />
documented observations <strong>of</strong> the course <strong>of</strong> disease. (1) Remission: Cases where a tumour could<br />
not be found at the localisation <strong>of</strong> the primary tumour at least twice, or the disappearance <strong>of</strong><br />
distant metastases. (2) Uncertain remission: Cases where a tumour could not be found at the<br />
localisation <strong>of</strong> the primary tumour once <strong>and</strong> possibly the disappearance <strong>of</strong> distant metastases.<br />
(3) Regression: Cases where regression <strong>of</strong> the primary tumour could be documented,<br />
independent <strong>of</strong> the development <strong>of</strong> distant metastases, without a previous increase in the<br />
primary tumour. (4) Uncertain regression: Cases with regression <strong>of</strong> the primary tumour after<br />
initial increase <strong>and</strong> cases with a documented disappearance <strong>of</strong> distant metastases with a<br />
previous or simultaneous increase in the primary tumour.<br />
The total remission rate <strong>of</strong> 22% (73 cases) is relatively high (see Table 4.1). A statistically<br />
significant difference cannot be shown either between Iscador <strong>and</strong> placebo (single sided test, p<br />
= 0.10) or between Iscador <strong>and</strong> Polyerga (single sided test, p = 0.2). However, considering the<br />
strict conditions <strong>of</strong> the study, it is remarkable that the rate <strong>of</strong> remission was approximately a<br />
third higher under Iscador therapy <strong>and</strong> can be interpreted as a distinct trend.<br />
The situation is more or less the same, when the questionable category <strong>of</strong> uncertain reduction<br />
is omitted. The difference between the three therapy groups then becomes even less.<br />
For further results see 3.2 <strong>and</strong> 5.4.3.<br />
© Verein für Krebsforschung, CH-4144 Arlesheim